Study Age group Study design Disease severity
Kaufman et al. (2004) (46) and Staab et al. (2005) (51) 3-23 months Pimecrolimus (n=129) or vehicle (n=66) for 4 wks in double-blind RCT, followed by open-label treatment with pimecrolimus for 12 wks, then 4-wk follow-up without treatment Mild to very severe
Kapp et al. (2002) (47), Papp et al. (2004) (49), Papp et al. (2005) (67) and McKenna et al. (2006) (52) 3-23 months Pimecrolimus (n=204) or vehicle (n=47) for 1 yr in double-blind RCT, followed by 1-yr open-label phase consisting of 76 patients who received pimecrolimus for 2 years Mild to very severe
Ho et al. (2003) (50) 3-23 months Pimecrolimus (n=123) or vehicle (n=63) for 6 wks in double-blind RCT, followed by 20-wk open-label extension with pimecrolimus Mild to moderate
Sigurgeirsson et al. (2015) (58) ≥3-<12 months Pimecrolimus (n=1,205) or TCS (n=1,213) for 5 yrs in randomised, open-label, parallel group study Mild to moderate
Schneider et al. (2016) (30) and Spergel et al. (2015) (33) 3-18 months Pimecrolimus (n=543) or vehicle (n=544) for 3 yrs in double-blind RCT, followed by open-label extension, including only patients without diagnosis of asthma, who were treated with pimecrolimus for 3 yrs or until the age of 6 yrs Mild to very severe